MAUDE Adverse Event Report: REFER TO SECTION H10 MICRUSFRAME18 11MM X 37CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181137
Medical Device Problem Codes	Off-Label Use (1494); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Procode: krd/hcg.(b)(4).Concomitant med products due to character limitation: excelsior1018 (stryker) microcatheter, angio guiding catheter, and a enpower detachment control box dcb2000500 (dcb2).Initial reporter - the customer contact information, including name, occupation, phone, fax, and e-mail, was not reported.(b)(4).The product is not available for evaluation and testing.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during an emergent coil embolization of a splanchnic artery aneurysm, the 11mm x 37cm micrusframe 18 (mfr181137/s13144) thermo-mechanical coil was selected as the first coil with the enpower (ecb00018200/s14342) control cable, but an electric conduction failure occurred.The coil and control cable were replaced, and competitor coils were placed in the aneurysm.The procedure was completed successfully without further incident or delay.No patient complications occurred as a result of the event.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product defect/damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.An excelsior1018 (stryker) microcatheter, an angio guiding catheter, and an enpower dcb2000500 detachment control box were also used in the case.The first physician prepped the products and started delivery of the coils.The complaint coil was chosen as the first coil with the complaint cable; however, the electric conduction failure occurred.The products will not be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Section b5: additional information received confirmed that the electrical failure occurred during attempt to detach in the patient.The coil was successfully removed from the patient without need for additional intervention; however, it was not reported if the embolic coil appeared damaged when removed.It was not reported if the same detachment control box (dcb) was used to detach subsequent coils or if a ¿system fault¿ light was visualized on the dcb.It was not reported if the connecting cable was damaged or if all connections appeared to fit properly without application of excessive force.It was also not reported if all lights illuminated upon pressing the ¿power¿ button or if the ¿detach¿ light illuminated and the audible signal beeped during the detachment cycle.It was not reported how long the procedure was delayed due to the event; however, the delay in procedure was not considered clinically significant.The concomitant dcb is not available for evaluation.No further information could be obtained.(b)(6).Complaint conclusion: as reported by a healthcare professional, during an emergent coil embolization of a splanchnic artery aneurysm, the 11mm x 37cm micrusframe 18 (b)(4) thermo-mechanical coil was selected as the first coil with the enpower (b)(4) control cable, but an electric conduction failure occurred while attempting to detail the coil in the patient.The coil and control cable were replaced, and competitor coils were placed in the aneurysm.The coil was successfully removed from the patient without need for additional intervention; however, it was not reported if the embolic coil appeared damaged when removed.The procedure was completed successfully without further incident or delay.No patient complications occurred as a result of the event.It was not reported how long the procedure was delayed due to the event; however, the delay in procedure was not considered clinically significant.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product defect/damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.It was not reported if the same detachment control box (dcb) was used to detach subsequent coils or if a ¿system fault¿ light was visualized on the dcb.It was not reported if the connecting cable was damaged or if all connections appeared to fit properly without application of excessive force.It was also not reported if all lights illuminated upon pressing the ¿power¿ button or if the ¿detach¿ light illuminated and the audible signal beeped during the detachment cycle.An excelsior1018 (stryker) microcatheter, an angio guiding catheter, and an enpower (b)(4) detachment control box were also used in the case.The first physician prepped the products and started delivery of the coils.The complaint coil was chosen as the first coil with the complaint cable; however, the electric conduction failure occurred.No further information could be obtained.The 11mm x 37cm micrusframe 18 not returned for evaluation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Failure to detach is a known potential product failure associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Per the ifu: ¿verify that the microcoil delivery system is fully connected, and no faults are indicted on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, and replace with a new microcoil system.If the system is free of faults, depress the detach button on the blue enpower dcb, the black dcb or the enpower control cable.The detach cycle light next to the button will illuminate and an intermittent tone will sound for the duration of the detachment cycle.If the light and audible tone do not activate, replace the dcb.¿ the ifu also states that the microcoil delivery system is intended for endovascular embolization of intracranial aneurysms.The product was used in the splanchnic artery.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and without the return of the complaint device; however, it is possible that procedural and handling factors may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MICRUSFRAME18 11MM X 37CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8129249
• Report Number: 3008114965-2018-00824
• Device Sequence Number: 1569727
• Product Code: KRD
• UDI-Device Identifier: 10886704078074
• UDI-Public: 10886704078074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: MFR181137
• Device Lot Number: S13144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/06/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1